In the long-term management of mild persistent asthma, shown in JPGL, anti-LTs are used as the first-line therapy. Bronchodilators such as theophylline and beta2-agonists are added. In the present study, the add-on effects of tulobuterol patch, a beta2 agonist, on patients receiving anti-LT will be compared with that of theophylline in order to evaluate the efficacy and safety (exacerbation of inflammation) of these major regimens.

1) Asthma symptoms (evaluate on the basis of the patient diary)
Asthma score: Symptoms, activities of daily living, nocturnal sleep, frequency of attacks, number of days without symptoms
2) Frequency of use of inhaled/oral beta2 agonists (as single doses)
3) Concomitant symptoms (adverse effects for which causal relationship with the treatment cannot be ruled out)
4) Frequency of occurence of adverse effects

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

tulobuterol patch (TP)

Interventions/Control_2

theophylline (Theo)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

4

years-old

<=

Age-upper limit

12

years-old

>=

Gender

Male and Female

Key inclusion criteria

&#61569; Children with bronchial asthma under treatment for mild persistent asthma.
&#61570; Children who still have wheezing and dyspnea despite of treatment with an anti-LT.
&#61571; Children who are 4~12 years of age and show stable PEF measurements (note).
Note) Stable PEF measurements are defined as that the difference between the second highest and the highest PEF measurement is lower 15% lower than the highest PEF measurement among three consecutive measurements of PEF.
&#61572; Children who (or whose parents) have given informed consent for participation in the present study.

Key exclusion criteria

&#61569; Children who are receiving long-acting beta2 agonists (tulobuterol patch or inhaled salmeterol) or oral beta2 agonists regularly.
&#61570; Children with a history of hypersensitivity to tulobuterol patch, and children with dermal diseases such as atopic dermatitis for whom treatment with tulobuterol patch are considered inappropriate.
&#61571; Children with hyperthyroidism, hypertension, heart disease or diabetes mellitus for whom treatment with beta2 agonists is considered inappropriate.
&#61572; Children with a history of serious adverse effects of tulobuterol.
&#61573; Children with a history of serious adverse effects of theophylline.
&#61574; Children with epilepsy, hyperthyroidism, acute nephritis, congestive heart failure or liver disorder for whom treatment with theophylline is considered inappropriate.
&#61575; Children with neurological dispositions (e.g., epilepsy, convulsions and abnormal EEG)
&#61576; Children with fever
&#61577; Any other children for whom participation in the survey is considered inappropriate by the attending physicians.